Coordinator, Gra, Lrr Mexico, Region Latam & Partner Business

CSL Ltd

Mexico
Hybrid
Local regulatory requirements
Health authority national engagements
New product registration
CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico sales affiliate, focusing on regulatory requirements, product registrations, and health authority engagements in the LATAM region. The ideal candidate should have extensive experience in local regulatory affairs and fluency in Spanish and English

Job Summary

  • Focus on local regulatory requirements and Health Authority national engagements for new product registration, lifecycle maintenance, import licenses, and batch release.
  • Responsible for evaluating advertising materials, with a primary focus on biological, biotechnological, and orphan drug products.
  • This is a hybrid role, offering a combination of onsite and remote work schedule.

Matching Summary

Match Score: 85

CSL Behring is seeking a Local Regulatory Responsible (LRR) for their Mexico sales affiliate, focusing on regulatory requirements, product registrations, and health authority engagements in the LATAM region. The ideal candidate should have extensive experience in local regulatory affairs and fluency in Spanish and English.

Skills & Requirements

Must-have

  • local regulatory requirements
  • Health Authority national engagements
  • new product registration
  • product lifecycle maintenance
  • obtaining import licenses
  • local product batch release
  • evaluation of advertising materials
  • biological, biotechnological, and orphan drug products
  • Spanish and English fluency

Nice-to-have

  • innovative regulatory strategies
  • industry trends
  • global environment
  • cross-functional teams

Key Requirements

  • 5+ years of professional experience in local regulatory affairs
  • Bachelor’s, Master’s, or equivalent degree in life-sciences
  • Expertise in local health authority systems i.e., DIGIPRIS, VUCEM
  • Required fluency in Spanish and English, oral and written

Work Rights

Not specified

Tailored Resume

Cover Letter